Off-label drug use in children should be rational

• Published in: Archives of disease in childhood Vol. 96; no. 9; pp. 870 - 871
• Main Authors: Bonati, Maurizio, Pandolfini, Chiara
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health 01.09.2011; BMJ Publishing Group; BMJ Publishing Group Ltd; BMJ Publishing Group LTD
• Subjects: Adolescent; Adolescents; Age; Biological and medical sciences; Child; Child Health; Clinical trials; Drug Approval; Drug dosages; Drug Labeling - standards; Drug use; Drug Utilization - standards; Drug Utilization - statistics & numerical data; Evidence-Based Medicine - methods; General aspects; Humans; Medical sciences; Miscellaneous; Off label prescribing; Off-Label Use - standards; Off-Label Use - statistics & numerical data; Pediatrics; Pharmaceutical industry; Practice; Prescription drugs; Prevention and actions; Public health. Hygiene; Public health. Hygiene-occupational medicine; Regulatory agencies; Substance abuse treatment; Europe; Human; Drug; Self prescription; Pediatrics; Rational irrational; Labelling; Child; Technical instructions; Recommendation; Public health
• ISSN: 0003-9888; 1468-2044
• DOI: 10.1136/archdischild-2011-300293

The off-label use of drugs has become an important issue throughout the world, and many studies have documented high rates everywhere, in different settings, therapeutic areas and age ranges. 3 Off-label use is critical in many areas, such as treatment of hypertension, 4 and in a few settings in which effective treatment options are often limited and prognoses are grim, as in oncology 5 or intensive care. 6 Since the 1990s, a number of measures were introduced in the USA and Europe to encourage the pharmaceutical industry to produce accurate information for prescribing and using drugs in children (drug labelling), to support clinical investigators in carrying out clinical trials with children and to ensure that children are taken into consideration throughout the regulatory process. 7 The number of paediatric clinical trials has grown during the last decade, and efforts on the part of regulatory agencies aimed at guaranteeing 'better medicines for children' and at reducing the need for off-label therapies and risks they carry have improved.